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Anticaries tests not completed for more than half of products subject to rule -- NDMA.

This article was originally published in The Tan Sheet

Executive Summary

ANTICARIES MONOGRAPH-REQUIRED BIOLOGICAL TESTING INCOMPLETE for about half of the fluoride dentifrice products subject to the final rule, the Nonprescription Drug Manufacturers Association informed FDA in a Sept. 5 letter. Based on a member survey, NDMA reported that 34 of 71 fluoride dentifrice products had not undergone the required testing as of August. The letter was submitted in support of an April 17 citizen's petition from NDMA and the Cosmetic, Toiletry and Fragrance Association that seeks a one-year extension (to Oct. 7, 1997) of the effective date for the new anticaries testing requirement. The petition had asked for the extension on the basis that industry needed more time to complete the required tests.

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